NCT00504647

Brief Summary

Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in some cases be severe. This appears in most cases to be due to an impairment of the filling of the heart, especially on exercise this limits the amount of blood the heart is able to pump. Several factors may contribute to this slow filling of the heart, including (1) The heart contracts and relaxes in an incoordinate way (called 'dyssynchrony') which is inefficient, and (2) The filling of the main pumping chamber (the left ventricle) may be impeded by high pressure in the other ventricle(the right ventricle)- in other words the left ventricle is 'squashed' by the right ventricle. This is known as diastolic ventricular interaction. Although drugs can improve the filling of the heart and relieve symptoms, some patients remain very symptomatic despite these drugs. The mechanisms responsible for the filling abnormality in patients with Hypertrophic Cardiomyopathy are similar to those seen in the much more common condition known as Heart Failure. A special type of pacemaker technique called 'Biventricular Pacing' has been shown to markedly improve symtoms in patients with heart failure. This form of pacing has been shown to improve both 'dyssynchrony' ( incoordination) and 'ventricular interaction' (squashed left heart) in patients with Heart Failure. We propose that Biventricular pacing may similarly improve these abnormalities in patients with Hypertrophic Cardiomyopathy, resulting in an improvement of symptoms. The study will focus on patients with the condition who have severe symtoms despite being on optimal currently available drug therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 20, 2007

Status Verified

July 1, 2007

First QC Date

July 18, 2007

Last Update Submit

July 18, 2007

Conditions

Hypertrophic Cardiomyopathy

Keywords

HypertrophicCardiomyopathyDiastolicVentricularInteractionBiventricularPacemaker

Outcome Measures

Primary Outcomes (1)

  • Peak Exercise Oxygen Consumption.

    4 month

Secondary Outcomes (2)

  • Myocardial Asynchrony Index

    4 months

  • Minnesota Quality of Life Questionnaire

    4 months

Interventions

Biventricular PacemakerDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Hypertrophic Cardiomyopathy
  • Ability to perform peak exercise oxygen consumption test.

You may not qualify if:

  • Left ventricular outflow tract gradient more than 30mmHg
  • Peak Oxygen consumption more than 75% of maximum predicted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Queen Elizabeth, University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

RECRUITING

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

The Heart Hospital

London, W1G 8PH, United Kingdom

RECRUITING

Related Publications (1)

  • Ahmed I, Loudon BL, Abozguia K, Cameron D, Shivu GN, Phan TT, Maher A, Stegemann B, Chow A, Marshall H, Nightingale P, Leyva F, Vassiliou VS, McKenna WJ, Elliott P, Frenneaux MP. Biventricular pacemaker therapy improves exercise capacity in patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise. Eur J Heart Fail. 2020 Jul;22(7):1263-1272. doi: 10.1002/ejhf.1722. Epub 2020 Jan 23.

    PMID: 31975494DERIVED

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicHypertrophyCardiomyopathiesHeart Murmurs

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Pacemaker, ArtificialElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Michael P Frenneaux, MBBS(Hons)

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrar Ahmed, MBChB

CONTACT

44(0) 121 414 591601ahmedi@gmail.com

Frenneaux P Frenneaux, MBBS(Hons)

CONTACT

44(0)121 414 6926m.p.frenneaux@bham.ac.uk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

June 1, 2006

Study Completion

August 1, 2008

Last Updated

July 20, 2007

Record last verified: 2007-07

Locations

GB(3)